Roche Diabetes Care, Inc.: Blood Glucose Monitoring System, Model Number 07400942001 ACCU-CHEK GUIDE METER ONLY MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intende

Is my product affected?

Blood Glucose Monitoring System, Model Number 07400942001 ACCU-CHEK GUIDE METER ONLY MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitor

• UPC 07400942001
• UPC 00365702702066

Check against the official notice below — it lists the full affected range.

What happened

Roche Diabetes Care, Inc. is recalling the Accu-Chek Guide Blood Glucose Monitoring System, Model Number 07400942001, due to potential power issues with the device. The recall affects approximately 21,094 units that were distributed nationwide in the United States as well as in Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, Germany, Denmark, Ecuador, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Croatia, Indonesia, India, Italy, Japan, South Korea, Lebanon, Lithuania, Luxembourg, Myanmar, Malaysia, Netherlands, Norway, Philippines, Pakistan, Portugal, Sweden, Singapore, Thailand, Taiwan, and South Africa.

The affected devices are those with serial numbers below XXX11000001 (where XXX represents the first three digits of the serial number). The recall record does not specify what remedy is available to consumers who have this device.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System.

Details from the source

Reason for recall: Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. Distribution: US Nationwide distribution and countries of AR, AT, AU, BE, BR, CA, CH, CL, DE, DK, EC, ES, FI, FR, GB, GR, HK, HR, ID, IN, IT, JP, KR, LB, LT, LU, MM, MY, NL, NO, PH, PK, PT, SE, SG, TH, TW, ZA. Quantity: 21,094 Lot/code info: Model Number : 07400942001 Device Identifier: 00365702702066 All serial numbers below XXX11000001 (where XXX is the first 3 digits of the serial number).

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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